Autoimmunity: Can a “King of Drugs” Be Born in China?

In November, The Lancet published a paper from Shanghai Changhai Hospital showing that systemic lupus erythematosus may be curable via a CAR-NK cell therapy— a milestone moment in autoimmune therapy. Humira once topped the global drug sales rankings for 11 consecutive years. Can the field of autoimmunity produce a Chinese “king of drugs”?

Autoimmune diseases: a vast, underestimated patient population and a heavy burden

Autoimmune diseases comprise a vast spectrum of hundreds of conditions, ranging from thyroiditis, which attacks a specific organ, to systemic lupus erythematosus, which involves the entire body, with highly variable clinical manifestations. What they share is the breakdown of immune tolerance, leading to chronic inflammation and tissue damage. Because the disease course is long, difficult to cure, and often affects young and middle-aged adults, the burden extends beyond individual suffering to a heavy socioeconomic load.

According to a 2024 systematic review covering Chinese adults, the prevalence of autoimmune diseases in China has reached 2.7%–3.0%, comparable to levels in Western countries. The following table lists several common autoimmune-related diseases:

It is noteworthy that, taking systemic lupus erythematosus as an example, the disease burden is growing rapidly. Between 2013 and 2017, the standardized prevalence in China’s urban areas surged from 21.85/100,000 to 47.61/100,000. Average annual per-patient medical expenditure is about USD 1,600, with drug costs accounting for more than 60%. This reveals a huge and still fast-expanding unmet clinical need.

Panorama of existing medicines: iteration from traditional suppression to precise targeting

China’s autoimmune treatment market has formed a multi-layered, dynamically evolving drug matrix, whose logic of evolution is a move from broad-spectrum immunosuppression toward precise targeted therapy.

a. Conventional disease-modifying antirheumatic drugs (csDMARDs)

• Representative drugs: methotrexate, leflunomide, sulfasalazine.
• Therapeutic principle and status: relieve inflammation by nonspecifically suppressing proliferation and function of immune cells. They remain the cornerstone and first-line for many autoimmune diseases (e.g., rheumatoid arthritis).
• Cost and market: low-priced and fully included in the national basic medical insurance, but monotherapy remission rates are limited and adverse effects are significant.

b. Biologics (bDMARDs): opening the era of targeted therapy

• TNF-α inhibitors: such as adalimumab (Humira) and infliximab. As first-generation biologics, they act by neutralizing the key inflammatory factor TNF-α, once creating the global “king of drugs” legend, but sales declined after patent expiry.
• Interleukin inhibitors: now the mainstream of the market and a growth engine.
• IL-4/13 inhibitors: dupilumab, which in 2024 became the new “sales champion” in autoimmunity with sales exceeding USD 14 billion, covering atopic dermatitis, asthma, and other multiple indications.
• IL-17 inhibitors: secukinumab and others, with a solid status in psoriasis and ankylosing spondylitis.
• IL-12/23 and IL-23 inhibitors: ustekinumab and others, used in psoriasis and Crohn’s disease.
• IL-6 inhibitors: tocilizumab, used in rheumatoid arthritis and more.
• B-cell-targeted drugs: such as rituximab (anti-CD20 mAb) and belimumab (BLyS inhibitor), focusing on diseases with aberrant B-cell activation such as lupus.
• Cost and market: annual treatment costs for originator biologics are typically RMB 80,000–200,000 (approximately USD 11,100–27,800). With the launch of domestic biosimilars (e.g., adalimumab biosimilars) and inclusion via insurance negotiations, prices have dropped substantially to RMB 30,000–60,000 per year (approximately USD 4,167–8,333), promoting market penetration via “price-for-volume.”

c. Small-molecule targeted drugs (tsDMARDs): a breakthrough in oral convenience

• Representative drugs: JAK inhibitors (tofacitinib, upadacitinib, etc.), TYK2 inhibitors, S1PR modulators, etc.
• Therapeutic principle: act on intracellular signaling pathways (e.g., JAK-STAT) to block the effects of multiple inflammatory cytokines simultaneously.
• Cost and market: annual treatment costs are about RMB 40,000–80,000 (approximately USD 5,556–11,111), with most already included in insurance. Their oral dosing markedly improves adherence and is rapidly gaining share—one of the most active areas in China for R&D and transactions.

Frontier breakthroughs: cell and immune therapies reshaping the treatment paradigm

Traditional medicines aim to “control” disease, whereas the new generation of cell therapies aims to “reset” the abnormal immune system, bringing hope of functional cures to the most refractory patients. In 2025, China achieved a series of world-class breakthroughs in this field:

a. Off-the-shelf CAR-NK therapy

• In November 2025, teams from Shanghai Changhai Hospital and Renji Hospital published in The Lancet and Annals of the Rheumatic Diseases, respectively, reporting significant efficacy of universal CD19 CAR-NK therapy in refractory systemic lupus erythematosus.
• Core advantages: batch manufacturing using healthy donor cells enables “on-the-shelf” supply, solving the high cost and long preparation cycle bottlenecks of autologous cell therapies.
• Clinical data: in the studies, most patients achieved deep remission and discontinued all immunosuppressants, with only mild side effects; safety was superior to CAR-T.

b. In vivo CAR-T therapy

• In September 2025, the First Affiliated Hospital of the University of Science and Technology of China reported in The New England Journal of Medicine the world’s first use of lipid nanoparticles (LNPs) to generate CAR-T cells directly in patients’ bodies to treat lupus.
• Disruptive change: completely bypasses complex ex vivo cell manufacturing; patients receive an LNP formulation like an infusion. This could reduce costs and timelines by orders of magnitude—key to broad adoption.

c. Universal CAR-T technology

In August 2025, a Peking University team published in Cell a “glycan shield” strategy that, via gene editing, enables donor T cells to evade immune rejection, preserving potent efficacy while achieving durable persistence—clearing a key technical hurdle for universal CAR-T in autoimmune diseases.

These advances mark a solid step in the paradigm shift of autoimmune therapy from “long-term medication control” to “one-time cell therapy cure.”

China’s autoimmunity market is on the eve of an explosion

a. Market status and scale

China’s autoimmune drug market is at the starting point of high-speed growth. According to Toubao Research Institute, market size grew from RMB 17.2 billion in 2019 (approximately USD 2.39 billion) to RMB 28.3 billion in 2023 (approximately USD 3.93 billion), a compound annual growth rate of 13.2%.

b. Core driving factors

• Transformation of diagnostic/treatment concepts and improved diagnosis rates: In the past, many patients were misdiagnosed or diagnosed late. Now, with strengthened rheumatology and immunology specialty construction, physicians and patients increasingly recognize “treat-to-target” and “reducing relapses,” pushing treatment rates upward.
• The pivotal lever of medical insurance reimbursement policy: Dynamic adjustments to the National Reimbursement Drug List have included many innovative biologics and small molecules, the most direct driver for volume expansion. For example, after inebilizumab for NMOSD (neuromyelitis optica spectrum disorder) entered insurance, it rapidly changed the treatment landscape. Through “price-for-volume,” insurance has greatly improved access to innovative drugs.
• Concentrated harvest of domestic innovative drugs and payment advantages: Since 2024, multiple domestic autoimmune innovative drugs (e.g., IL-4Rα and IL-17 inhibitors) have been approved and are entering a harvest period. Local companies have natural advantages in pricing and insurance access, better meeting the needs of price-sensitive patients and lower-tier markets.
• “Two-way rush” toward globalization: Chinese autoimmune innovators are not only commercializing domestically but also engaging deeply with global markets. In 2024, outbound licensing deals in China’s autoimmune field reached USD 3.1 billion, accounting for one-third of recent totals and involving frontier targets such as TL1A and TYK2. Meanwhile, multinational pharma is also bringing Chinese assets or technologies in via large transactions.

c. Future forecasts

• Toubao Research Institute forecasts that from 2024 to 2028, market size will grow from RMB 34.9 billion (approximately USD 4.85 billion) to RMB 88.0 billion (approximately USD 12.22 billion), with a compound annual growth rate as high as 26%. The growth drivers will be:
• Penetration improvement: higher diagnosis rates, deeper insurance coverage, and launches of affordable domestic drugs jointly driving treatment penetration from first-tier cities into broader markets.
• Therapy upgrades: patients moving from traditional drugs to more effective and convenient biologics and small-molecule targeted drugs, while cell therapies offer solutions for the most refractory cases.
• Indication expansion: like dupilumab, star drugs will continue to expand market boundaries through new indications.
• Technology integration: AI-assisted diagnosis and digital patient-management platforms will integrate with innovative therapies to enhance overall care efficiency.

Conclusion
China’s autoimmune therapy market is undergoing a profound transformation driven by the triple engines of awakened demand, payment reform, and supply-side innovation. The track is no longer merely the “cash cow” of multinational pharma; it is also a prime battleground where domestic innovators can pursue differentiated competition and even overtake on the curve. Future competition will be a comprehensive contest of target innovation, clinical development speed, commercial execution efficiency, and forward-looking technological布局 (such as cell therapies). Whether a Chinese “king of drugs” can emerge in the autoimmune field is highly anticipated.

[Disclaimer]: The above content reflects analysis of publicly available information, expert insights, and BCC research. It does not constitute investment advice. BCC is not responsible for any losses resulting from reliance on the views expressed herein. Investors should exercise caution.